clothianidin (ISO); (E)-1-(2-chloro-1,3-thiazol-5-ylmethyl)-3-methyl-2-nitroguanidine

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

17 - 28 Sep 1996

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1997

Report date:

1997

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

adopted 2015

Deviations:

yes

Remarks:

housing conditions slightly divergent, 6 animals were used, body weights only noted at the start of study

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

adopted 1992

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

433-460-1

EC Name:

-

Cas Number:

210880-92-5

Molecular formula:

C6H8ClN5O2S

IUPAC Name:

(E)-N'-[(2-chloro-1,3-thiazol-5-yl)methyl]-N-methyl-N''-nitroguanidine

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River UK Ltd, Margate, UK
- Age at study initiation: 11 - 14 weeks
- Weight at study initiation: 2.42 - 2.85 kg
- Housing: individually housed in floor-pens with a minimum floor area of 0.6 m²
- Diet: pelleted SQC TRB Rabbit Diet 9603 (Harlan Teklad, Bicester, UK), ad libitum
- Water: mains water, ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16 - 22
- Humidity (%): 40 - 80
- Air changes (per hr): at least 10
- Photoperiod (hrs dark / hrs light): 10/14

IN-LIFE DATES: From: 17 Sep 1996 To: 28 Sep 1996

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

water

Remarks:

The dermal test site was moistened with 0.1 mL distilled water immediately before application.

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.5 g

VEHICLE
- Amount(s) applied: 0.1 mL distilled water was immediately applied on the dermal test site before application

Duration of treatment / exposure:

4 h

Observation period:

Observation period: 72 h
Reading time points: 1, 24, 48 and 72 h

Number of animals:

1 female (step 1) and 5 males (step 2)

Details on study design:

TEST SITE
- Area of exposure: 30 x 20 mm area
- Type of wrap if used: test site was covered by a larger gauze patch (40 x 40 mm) and an open weave, elasticated adhesive bandage was wrapped firmly around the torso (semi-occlusive dressing)

REMOVAL OF TEST SUBSTANCE
- Washing: treated skin was lightly brushed clean of any solid residues and swabbed with moist cotton wool
- Time after start of exposure: 4 h

OBSERVATION TIME POINTS
1, 24, 48 and 72 h

SCORING SYSTEM:
- Method of calculation: Draize scoring system

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

edema score

Basis:

mean

Remarks:

of 6 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 2

Irritation parameter:

erythema score

Basis:

mean

Remarks:

of 6 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Irritant / corrosive response data:

No irritation reactions or other dermal changes were observed hi any animal at any time during the observation period.

Other effects:

There were no signs of toxicity or ill health in any rabbit during the observation period.

Applicant's summary and conclusion

Interpretation of results:

other: According to the classification criteria of the CLP Regulation (EU) No. 1272/2008, no classification is required.

Conclusions:

The study is in concordance with the OECD TG 404 (1992). Therefore, the study is considered acceptable and the outcome can be reported as valid.
A single semi-occlusive application of 0.5 g test substance to intact rabbit skin for 4 h elicted no skin irritation reaction. The individual mean score for the 24, 48 and 72-h readings were 0 for all animals. According to the criteria of the CLP Regulation (EU) No. 1272/2008, no classification is required.